Can’t lay your hands on a pulse oximeter? 1976 law, FDA regulation are among reasons

Because low blood oxygen may be an early symptom of serious COVID-19 disease, interest has quickly amounted among consumers and medical professionals in enabling wider access to the decades-old technology. Ordinarily inexpensive and widely available, the small finger-clasp devices are now back ordered on long delays in online commerce. And now for the regulatory rub: “The Apple Watch actually contains hardware to measure blood-oxygen level, but under current FDA regulation, the function is disabled.” And while the old finger-clasp technology is luckily grandfathered in, technologies updating the idea face an onerous path to market under the Medical Device Regulation Act of 1976, which mandates FDA review. “Samsung’s Galaxy phones possessed the capacity to read blood oxygen as well as pulse through its built-in Samsung Health app — until the most recent version, the S20, which suspended the function, likely due to regulatory and legal concerns.” [James Copland, City Journal]

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